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Janssen R&D, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting an Established Products Internal Medicine/Infectious Diseases Co-Op (EP IM/ID Co-Op). Established Products (EP) is a functional area within the Global Medical Organization of Janssen Research and Development, responsible for the late lifecycle management and optimization of a variety of legacy products across diverse therapeutic areas.
The EP IM/ID Co-Op position supports the Therapeutic Area Portfolio Clinical Team and is dedicated to maximizing the value of this portfolio through the execution of all phases of clinical development. The role provides active medical and scientific contributions to cross-functional clinical teams to support the successful completion of clinical projects and deliverables that enable worldwide registrations for new indications, enhancements to the label, and compliance with regulatory commitments for products in the market and in development.
Responsibilities
- Work with the Clinical and overall EP IM/ID compound development teams (CDT) and their internal and external partners in executing specific tasks and projects related to clinical studies.
- Collaborate with Clinical Leaders on clinical trial concept and protocol development, executing clinical studies for new formulations, post-approval commitments, and new indications.
- Contribute to the creation of Clinical Study Reports (CSRs), publication of clinical research findings, and presentations to relevant FDA, EMA, or other Health Authorities.
- Participate in cross-functional teams for evaluating new product ideas and related new technologies; review medical literature, clinical, medical, and market access plans.
Qualifications
- Candidates must be enrolled in an accredited college/university pursuing MD, PhD, Pharm D, or any other health care-related advanced degree, with emphasis in Biological sciences and Public Health.
- Bachelor's degree in Biological Sciences with strong clinical experience or preferably enrolled in a Master's degree in a Clinical Science or related field; Paramedical professionals (including nurse practitioners, physician's assistants, and midwives) with strong clinical/research backgrounds will be considered.
- Previous experience in the development and/or execution of phase 2-3 clinical studies and a strong background in clinical pharmacology and/or internal medicine/infectious diseases is desirable.
- Passion for science and operational excellence.
- Strong problem-solving skills for developing creative solutions and meeting project objectives.
- Demonstrated ability in strategic thinking and contingency planning with respect to project objectives.
- Candidates must be available to work Full Time for the total duration of the role (6 months).
- Candidates must be legally authorized to work in the United States and not require sponsorship for employment visa status (e.g., H1-B status) now or in the future.
- Demonstrated leadership is preferred.
- Detail-oriented, highly organized, and able to manage multiple tasks while maintaining a strong sense of urgency.
- Ability to work independently as well as in a matrix team environment.
- Strong interpersonal skills and effectiveness in a collaborative team environment.
- Proficiency with Microsoft Office, including Word, Excel (high proficiency with pivot tables and graphs), and PowerPoint, along with strong oral and written communication skills. Additional technical competencies in SharePoint and information technology systems are highly desirable, as is experience with PubMed and other literature databases.
- Experience working on academic and/or industry clinical trials, particularly in areas of Global Public Health in underdeveloped countries, is strongly preferred.
- A minimum GPA of 3.0 is strongly preferred.
- Participation in campus/community service activities is desired.
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